Evaluating the Effectiveness of Decitabine With Gemcitabine, Oxaliplatin for Relapsed/Refractory Peripheral T-cell Lymphoma

Phase II, Multicentre, Randomized Study of Decitabine Plus GemOx Versus GemOx for Relapsed/Refractory Peripheral T-cell Lymphoma

To establish an optimal therapeutic strategy for patients with peripheral T-cell lymphoma (PTCL) who have relapsed after first-line chemotherapy or are refractory to initial treatment, we designed a phase II trial to evaluate the efficacy of a multidrug combination regimen comprising decitabine, gemcitabine, and oxaliplatin as a second-line or later treatment. This clinical trial is based on a review of existing literature, which supports the rationale for using this three-drug combination.

Study Overview

• Status: Terminated
• Conditions: Peripheral T-cell Lymphoma (PTCL)
• Intervention / Treatment: Drug: Decitabine with GemOx; Drug: GemOx

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must meet all of the following criteria to be considered eligible.

  1. Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have either relapsed after first-line chemotherapy or experienced disease progression due to refractory disease, and who are deemed eligible for further chemotherapy.
  2. Age ≥ 19 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

  4. Adequate bone marrow function, defined as:

     1. White blood cell count ≥ 3,000/μL
     2. Absolute neutrophil count ≥ 2,000/μL
     3. Platelet count ≥ 75,000/μL
     4. Hemoglobin ≥ 8.0 g/dL Note: Transfusions within 1 week prior to screening are not permitted.
  5. Adequate renal function, defined as serum creatinine ≤ 1.5 × upper limit of normal (ULN).

  6. Adequate hepatic function, defined as:

     1. Serum total bilirubin ≤ 1.5 × ULN
     2. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases) Note: Patients with hepatic dysfunction due to underlying disease may be enrolled at the investigator's discretion.
  7. Presence of measurable disease.
  8. Ability to understand and provide written informed consent.
  9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  10. Female patients of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) test within 3 weeks prior to treatment, and must agree to use effective contraception (e.g., barrier methods) from 4 weeks prior to treatment initiation through the study duration.

Exclusion Criteria:

• Patients will be deemed ineligible if they meet any of the exclusion criteria listed below.

  1. Diagnosis of a malignancy other than lymphoma within the past 3 years.
  2. More than two prior lines of chemotherapy for lymphoma. Note: Autologous stem cell transplantation is considered part of one treatment regimen.
  3. Evidence of uncontrolled central nervous system involvement.
  4. History of solid organ or allogeneic stem cell transplantation.
  5. Uncontrolled seizures or significant psychiatric disorders.
  6. Pregnancy or breastfeeding.
  7. Any other serious illness or medical condition deemed inappropriate by the investigator.
  8. Presence of grade ≥2 peripheral neuropathy.
  9. Prior treatment with gemcitabine for lymphoma.
  10. History of HIV infection or active, uncontrolled bacterial, viral, or fungal infections.
  11. Surgery within 14 days prior to enrollment, or failure to recover from surgical complications.
  12. Patients currently receiving thoracic radiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decatabine + GemOx (gemcitabine, oxaliplatin)	Drug: Decitabine with GemOx; Each treatment cycle consists of 3 weeks, and a total of 6 cycles will be administered. The drugs will be administered sequentially in the following order: decitabine, gemcitabine, and oxaliplatin. Decitabine will be administered at a dose of 7.5 mg/m² on days 1 to 5; gemcitabine at 1000 mg/m² on days 1 and 8; and oxaliplatin at 100 mg/m² on day 1 of each cycle.
Active Comparator: GemOx (gemcitabine, oxaliplatin)	Drug: GemOx; Each treatment cycle spans 3 weeks, with a total of 6 cycles planned. Gemcitabine will be administered at a dose of 1000 mg/m² on days 1 and 8, and oxaliplatin at 100 mg/m² on day 1 of each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The objective response rate (ORR) is defined as the proportion of patients who achieve either a complete response (CR) or a partial response (PR) to treatment, as assessed by Lugano criteria.	From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete response (CR) rate	From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Time to response (TTR)	From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Progression-free survival (PFS)	From cycle 1 day 1 to study completion, an average of 2 years.
Overall survival (OS)	From cycle 1 day 1 to study completion, an average of 2 years.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: PTCL; Decitabine; GemOx; Randomized Phase II trial
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Decitabine
• Other Study ID Numbers: 1904-052-1027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No